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Keywords:

  • congenital anomalies;
  • drug exposure;
  • drug safety;
  • pharmacoepidemiology

Abstract

Pregnancy exposure registries systematically evaluate pregnancies and outcomes exposed to a medicinal compound or device during the gestational period. Historically, such programs partner an academic institution with one or more pharmaceutical companies or are run solely by a pharmaceutical company. However, other examples abound. This article describes what a pregnancy exposure registry is, as well as selected methodological challenges they face, using real examples and applications. Birth Defects Research (Part A), 2009. © 2008 Wiley-Liss, Inc.